BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3933456 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03864
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED DURING THE MANUAL PRIME. CUSTOMER STATED THAT SHE IS UNABLE TO EXIT THE PREPARING TO PRIME LOOP AND INSULIN CONTINUES TO DRIP AFTER MOTOR STOPS DURING MANUAL PRIME. CUSTOMER REPORTED THE DRIVE SUPPORT CAP ON THE INSULIN PUMP IS RECESSED. HIGH BLOOD GLUCOSE OF 476 MG/DL CUSTOMER STATED WILL BE TRITING WITH INSULIN MANUAL INJECTION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411147 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR